- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746274
An Online Large-group One-session Training to Enhance Positive Mental Health
The More the Merrier and Brevity is the Soul of Wit? Efficacy of a Multicomponent Positive Psychological Intervention Conducted in an Online Large-group One-session Format
Study Overview
Status
Conditions
Detailed Description
In general, the investigators expect an increase in positive mental health in the multicomponent positive psychological intervention (MPPI) group. This effect should be present at the assessment points one month and six months after training. Furthermore, the increase in positive mental health in the MPPI group is expected to be larger than in the two control groups (cognitive intervention targeting dysfunctional thoughts [CIDT], waitlist). Furthermore, the investigators hypothesize participants to benefit from the MPPI in terms of other constructs related to mental health, i.e. self efficacy, happiness, wellbeing, positive emotions, and life satisfaction, in the long term. This increase is expected to be larger in the MPPI than in the two control groups. A decrease in depressive symptoms is hypothesized to occur in the MPPI as well as in the CIDT group.
The sample under investigation will be a community sample. All participants can attain the training for free and there is no payment for participation. One week before the first training day, the random allocation to the three groups will take place. Two days before the first training day, all participants are asked to fill out another survey through a link sent to them via e-mail. This survey comprises all outcome measures. The same procedure is carried out one day after, one month after and six months after the first training day. After the last assessment time point, the training for the waitlist control group will be conducted.
The target sample size is 300 participants (100 per group). The investigators will attempt to recruit more participants, assuming that not all will complete the study, especially the assessment after six months.
The investigators used the software program G*Power to conduct a power analysis. The goal was to obtain .95 power to detect a small effect size of .1 at the standard .05 alpha error probability. The investigators extended the calculated sample size of 264 participants to a target sample size of 300 participants as there was no study before that compared an online multicomponent large-group one-session training to enhance positive mental health with an online large-group one-session intervention targeting dysfunctional thoughts. Therefore, the effect size for the comparison of these two groups could be smaller than f = .1.
The primary outcome measure will be analyzed with a 3x2 repeated measures ANOVA.
For all other outcome measures, the investigators will use 3 x 4 between-within repeated measures ANOVAs (rmANOVA) to analyze the results. The first factor is a between-subjects factor that comprises the three groups MPPI, CIDT and waitlist control group. The second factor is a within-subjects factor reflecting the four assessment time points two days before the intervention, one day after the intervention, one month after the intervention and six months after the intervention. This analysis will be conducted for positive mental health, life satisfaction, affect, generalized self-efficacy, happiness, wellbeing, stress perception, positive and negative aspects of mental health, depression, anxiety and stress, social support and media-related variables. Before these analyses are carried out, correlations among the outcome measures are calculated. If outcome measures correlate significantly high (above .5), they will be first analyzed together in a between-within repeated measures MANOVA to control for alpha-error accumulation. After that, the separate analyses will be conducted. Furthermore, there will be paired comparisons between each of the three groups, reducing the first between-subjects factor in the between-within rm(M)ANOVA to two levels. For each group, rmANOVAs will be conducted to analyze the change of outcome variables over time entailing paired contrasts between the assessment time points.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bochum, Germany, 44801
- Ruhr-University of Bochum
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Aged 18 years or above
Exclusion Criteria:
• Not having the appropriate technical equipment for participation in a videoconference
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: Waitlist Control Group
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EXPERIMENTAL: Online large-group one-session multicomponent positive psychological intervention
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The intervention is aimed at enhancing positive mental health by using components from positive psychology or positive psychotherapy.
These include for exapmle using character strengths, savoring the moment, goal setting and goal attainment.
The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
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ACTIVE_COMPARATOR: Online large-group one-session cognitive intervention targeting dysfunctional thoughts
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The intervention is aimed at reducing dysfunctional thoughts by applying strategies known from the cognitive therapy of depression.
These include for example identification of automatic thoughts and cognitive biases as well as evaluating evidence for and against automatic thoughts.
The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
Time Frame: two days before the intervention and one month after the intervention
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9 items, 4-point Likert scale, large change in a positive direction means better outcome
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two days before the intervention and one month after the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change on positive mental health scale (german version; Lukat, Margraf, Lutz, van der Feld, & Becker, 2015)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention
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9 items, 4-point Likert scale, large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention (already specified as primary outcome measure), six months after the intervention
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change on generalized self efficacy scale (german version; Schwarzer & Jerusalem, 1999)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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10 items, 4-point Likert scale, large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on satisfaction with life scale (german version; Glaesmer, Grande, Braehler, & Roth, 2011)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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5 items, 7-point Likert scale, large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on subjective happiness scale (Lyubomirsky & Lepper, 1999; german version)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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4 items, 7-point Likert scale, large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on positive and negative affect schedule (german version; Breyer & Bluemke, 2016)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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20 items, 5-point Likert scale, two subscales negative affect: large change in a negative direction means better outcome positive affect: large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change in the degree of subjectively experienced stress concerning a specific situation measured with the questionnaire "primary appraisal secondary appraisal" (PASA; german version; Gaab, 2009)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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The questionnaire assesses the two processes proposed in Lazarus' transactional model of stress: primary appraisal and secondary appraisal. Each process is operationalized by two subscales (yielding four level 1 subscales and two level 2 subscales). The subscales will be analyzed seperately and a stressindex will be calculated by calculating the difference between primary and secondary appraisal. 16 items, 6-point Likert-scale, for the stressindex, large changes in a negative direction mean better outcome |
two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on mental health continuum - short form (Keyes et al., 2008; german translation)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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14 items, 6-point Likert scale, three subscales emotional wellbeing, subjective wellbeing and personal wellbeing, large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on general health questionnaire (german version; Linden et al., 1996)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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12 items, 4-point Likert scale, large change in a negative direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on depression anxiety stress scale (DASS-21; german version; Nilges & Essau, 2015)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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21 items, 4-point Likert scale, 3 subscales that are analyzed separately (depression, anxiety, stress), large change in a negative direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on brief form of the perceived social support questionnaire (german version; Lin, Hirschfeld, & Margraf, 2019)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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6 items, 5-point Likert scale, large change in a positive direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change of frequency of media use (TV, internet, gaming, smartphone, social media)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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7-point scale for each medium, large change in a negative direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change of use of social media (frequency of social media use of different platforms, e.g. facebook, tumblr; accesses per day; time per day)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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frequency: 7-point scale, accesses per day and time per day measured continously, large change in a negative direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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change on brief version of the Bergen Social Media Addiction Scale (german version; Brailovskaia, Schillack, & Margraf, 2020)
Time Frame: two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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6 items, 5-point Likert scale, large change in a negative direction means better outcome
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two days before the intervention, one day after the intervention, one month after the intervention, six months after the intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
general rating of success
Time Frame: one day after the intervention
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how helpful was the training for you (0 = not helpful at all; 10 = extremely helpful); how successful was the training for you ( 0 = not successful at all; 10 = extremely successful); did the training meet your expectations (0 = did not meet my expectations at all; 10 = met all my expectations); would you recommend the training to a friend (0 = would not recommend it; 10 = would absolutely recommend it)
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one day after the intervention
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practice / use of the learned strategies
Time Frame: one month after the intervention, six months after the intervention
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how often did you practice / use the learned strategies (0 = never; 10 = always)
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one month after the intervention, six months after the intervention
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helpfulness of the learned strategies
Time Frame: one month after the intervention, six months after the intervention
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how helpful was the use of the learned strategies (0 = not helpful at all; 10 = extremely helpful)
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one month after the intervention, six months after the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Svenja Schaumburg, M. Sc., Ruhr University of Bochum
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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